Prone position for acute respiratory distress syndrome and the hazards of meta-analysis.

BACKGROUND: Researchers have tried unsuccessfully for many years using randomized controlled trials to show the efficacy of prone ventilation in treating ARDS. These failed attempts were of use in designing the successful PROSEVA trial, published in 2013. However, the evidence provided by meta-analyses in support of prone ventilation for ARDS was too low to be conclusive. The present study shows that meta-analysis is indeed not the best approach for the assessment of evidence as to the efficacy of prone ventilation. METHODS: We performed a cumulative meta-analysis to prove that only the PROSEVA trial, due to its strong protective effect, has substantially impacted on the outcome. We also replicated nine published meta-analyses including the PROSEVA trial. We performed leave-one-out analyses, removing one trial at a time from each meta-analysis, measuring p values for effect size, and also the Cochran's Q test for heterogeneity assessment. We represented these analyses in a scatter plot to identify outlier studies influencing heterogeneity or overall effect size. We used interaction tests to formally identify and evaluate differences with the PROSEVA trial. RESULTS: The positive effect of the PROSEVA trial accounted for most of the heterogeneity and for the reduction of overall effect size in the meta-analyses. The interaction tests we conducted on the nine meta-analyses formally confirmed the difference in the effectiveness of prone ventilation between the PROSEVA trial the other studies. CONCLUSIONS: The clinical lack of homogeneity between the PROSEVA trial design and the other studies should have discouraged the use of meta-analysis. Statistical considerations support this hypothesis, suggesting that the PROSEVA trial is an independent source of evidence.

Adherence to capecitabine in preoperative treatment of stage II and III rectal cancer: do we need to worry?

BACKGROUND: Preoperative oral capecitabine plus radiotherapy has been progressively adopted in oncology units to provide more convenient care to patients with rectal cancer, but little is known about adherence to this therapy. PATIENTS AND METHODS: Prospective, multicentre observational study in six hospitals in metropolitan Barcelona (Spain), in patients with stage II and III rectal cancer. Assessment of adherence was based on the medical report in the clinical history, a patient questionnaire and a pill count in the pharmacy service upon finalization of treatment. Patients were considered adherent if they had taken 80%-110% of the prescribed treatment. We evaluated clinical variables, adverse effects, anxiety and depression (using the hospital anxiety depression scale [HADS]), and quality of life (EORTC QLQ-30). We analysed adherence-associated variables using a logistic regression model and concordance between adherence measures by means of the modified Kappa index. RESULTS: We included 119 participants. Adherence measures showed little concordance between the assessment methods used: adherence was 100% according to the clinical history, 83.2% according to self-report and 67.9% according to the pill count. In the multivariable analysis, the most relevant variable associated with non-adherence was anxiety prior to treatment (adjusted odds ratio [ORa] 6.96, 95% confidence interval [CI] 1.48-32.7). We did not observe any relevant association between adherence and clinical variables and baseline quality of life parameters. CONCLUSIONS: Adherence to short-term oral neoadjuvant treatment in rectal cancer may be a clinical problem, and it should be acknowledged and systematically evaluated by clinicians during treatment. The limited concordance between different measures of adherence highlights the challenges in monitoring it and the need to use different approaches to assess its impact in clinical practice.

Further evidence for preoperative chemoradiotherapy and transanal endoscopic surgery (TEM) in T2-3s, N0, M0 rectal cancer

Purpose: Preoperative chemoradiotherapy and local excision via transanal endoscopic surgery (TEM) in T2-3s,N0,M0 rectal cancer achieve promising results in selected patients. We describe our long-term follow-up experience with this combination, and evaluate complete clinical and pathological responses, local recurrence and overall survival. Methods: The prospective observational follow-up study carried out since 2007. Out of 476 consecutive patients treated with TEM, we selected those with adenocarcinoma of low or moderate grade of differentiation, clinical stages T2-superficial T3,N0,M0, who refused radical surgery. Preoperative chemoradiotherapy comprised 5-fluorouracil or capecitabine combined with radiotherapy at a dose of 50.4 Gy. TEM was performed after 8 weeks. Complications were recorded and long-term follow-up was conducted. Results: Fifteen patients undergoing preoperative chemoradiotherapy and TEM (median age 76 years, 95 % CI 70.3-80.4, and median follow-up 38 months, 95 % CI 20-44) were studied. No local recurrence was observed, and only one patient (6.7 %) presented systemic relapse. The overall survival was 76 %. Complete clinical response was achieved in seven patients (46.7 %) and complete pathological response in four (26.7 %). With regard to toxicity associated with neoadjuvant treatment, four patients (26.7 %) developed grade 3 adverse effects; no grade 4 or 5 adverse effects were observed. There was no postoperative mortality. Conclusions: The results of our study, with a response rate of 26.7 % and without local relapse, support the treatment of T2-3s,N0,M0 of rectal cancer with preoperative chemoradiotherapy and local excision (TEM) (AU)

No disponible

Further evidence for preoperative chemoradiotherapy and transanal endoscopic surgery (TEM) in T2-3s,N0,M0 rectal cancer.

PURPOSE: Preoperative chemoradiotherapy and local excision via transanal endoscopic surgery (TEM) in T2-3s,N0,M0 rectal cancer achieve promising results in selected patients. We describe our long-term follow-up experience with this combination, and evaluate complete clinical and pathological responses, local recurrence and overall survival. METHODS: The prospective observational follow-up study carried out since 2007. Out of 476 consecutive patients treated with TEM, we selected those with adenocarcinoma of low or moderate grade of differentiation, clinical stages T2-superficial T3,N0,M0, who refused radical surgery. Preoperative chemoradiotherapy comprised 5-fluorouracil or capecitabine combined with radiotherapy at a dose of 50.4 Gy. TEM was performed after 8 weeks. Complications were recorded and long-term follow-up was conducted. RESULTS: Fifteen patients undergoing preoperative chemoradiotherapy and TEM (median age 76 years, 95 % CI 70.3-80.4, and median follow-up 38 months, 95 % CI 20-44) were studied. No local recurrence was observed, and only one patient (6.7 %) presented systemic relapse. The overall survival was 76 %. Complete clinical response was achieved in seven patients (46.7 %) and complete pathological response in four (26.7 %). With regard to toxicity associated with neoadjuvant treatment, four patients (26.7 %) developed grade 3 adverse effects; no grade 4 or 5 adverse effects were observed. There was no postoperative mortality. CONCLUSIONS: The results of our study, with a response rate of 26.7 % and without local relapse, support the treatment of T2-3s,N0,M0 of rectal cancer with preoperative chemoradiotherapy and local excision (TEM).

Social class and type of schizophrenia.

OBJECTIVE: Current and past research strongly indicates a high prevalence of schizophrenia in the lower class in the USA and other stratified societies. To date, no study has tested for a connection between type of schizophrenia and socioeconomic status (SES). We tested for an interrelationship between schizophrenic subtype, SES and race. METHODS: Positive and negative symptom scales were used to evaluate 436 schizophrenic patients at a state hospital in the USA. All patients were also diagnosed by DSM standards. Social class of origin was assessed by the Occupational Classification Distributions of the U.S. Bureau of the Census. Multivariate analysis was conducted with the likelihood ratio chi-square. RESULTS: We uncovered a distinct propensity for deficit schizophrenia to be elevated among the poor. The finding presents as a pure SES effect since the likelihood of deficit schizophrenia does not vary by race when social class is held constant. CONCLUSION: The finding is potentially an important new insight into the epidemiology of schizophrenia. It offers a better understanding for poor outcome among lower class patients in stratified societies such as the United States. It is also consistent with longitudinal research by European investigators.

Analysis of an anxiolytic technique applied in 1179 patients undergoing oral surgery.

AIM: The aim of this study was to evaluate the effects of sedation with benzodiazepines in a large population of patients undergoing oral surgery and age-related implications. METHODS: A group of 1 179 consecutive patients undergoing oral surgery in the Dental Clinic of the University of Padua between 2001 and 2003 was evaluated by analysing their anaesthesiological records. The patients were divided into 5 age groups. All were pre-sedated with chlordemethyldiazepam per os, while induction of maximum subjective tranquillity was obtained with fractionated doses of intravenous diazepam. Arterial pressure (AP), heart rate (HR), anxiety level, pathologies, drugs taken, types of intervention, techniques of loco-regional anaesthesia, immediately preoperative AP and HR and tranquillity, intraoperative AP and HR, data regarding postoperative psychomotor recovery, complications and drugs used for the treatment of perioperative pain, were evaluated in each group. RESULTS: Most of the patients (679) were in the 45-64 year-old group. Cardiovascular, respiratory and digestive pathologies proved to be age-dependent. Control AP and HR respectively increased and decreased with age. The doses of chlordemethyldiazepam used induced age-dependent preoperative tranquillity levels. The doses of i.v. diazepam necessary to obtain maximal preoperative subjective tranquillity fell as a function of age. The AP and HR values respectively increased during intervention and decreased in the first hour of intervention. Normal psychomotor recovery was less evident in older patients. The most significant corrective intraoperative interventions consisted of the administration of sublingual hypotensive drugs and in the immediate treatment of some cases of orthostatic hypotension and vaso-vagal syncope. CONCLUSIONS: The sedation technique and the antistress procedures employed proved safe and the intra- or postoperative complications almost non-existent. The variations observed in the parameters considered are compatible with the greater age of the treated subjects.

Prenatal illness and subtypes of schizophrenia: the winter pregnancy phenomenon.

Seasonality of birth patterns is examined among a sample of 801 patients with schizophrenia separated into Type I and Type II schizophrenia. Findings indicate that both groups of patients were in utero during the winter but during different trimesters. Patients with Type I schizophrenia were more likely to be in utero during the third trimester. Patients with Type II schizophrenia were more likely to have been in the womb during the first trimester. Implications for fetal brain development are discussed.

A multifaceted approach to psychodrama in a day treatment center.

Staff at the day treatment center at Norristown (Pa.) State Hospital have found several ways of using psychodrama to facilitate information gathering, diagnostic decision-making, and treatment planning and implementation. They use behavioral techniques such as role rehearsal and modeling. In addition they use techniques such as the mirror image, in vivo dramas, and slight deception to facilitate catharsis. These approaches, which broaden the applicability of psychodrama, are illustrated by case examples.